EDWARDS LIFESCIENCES SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE
Report
- Report Number
- 2015691-2024-08121
- Event Type
- Injury
- Date Received
- October 25, 2024
- Date of Event
- September 6, 2024
- Report Date
- March 21, 2025
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- PMA / PMN Number
- P14003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL MDR IS BEING SUBMITTED DUE TO NEW INFORMATION RECEIVED. SECTIONS B3, B5, G6, H2 AND H6 (HEALTH EFFECT-CLINICAL CODE) AND CONCLUSIONS IN THIS SECTION HAVE BEEN UPDATED. PER THE INSTRUCTIONS FOR USE (IFU), PERMANENT OR TRANSIENT NEUROLOGICAL EVENTS SUCH AS TRANSIENT ISCHEMIC ATTACK (TIA) AND STROKE ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE OVERALL TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE AND THE USE OF THE EDWARDS TRANSCATHETER HEART VALVE (THV) DEVICES. ACCORDING TO THE LITERATURE REVIEW, AND AS DOCUMENTED IN A CLINICAL TECHNICAL SUMMARY WRITTEN BY EW, STROKE IS RECOGNIZED IN THE LITERATURE AS A WELL-KNOWN COMPLICATION IN A SMALL NUMBER OF PATIENTS UNDERGOING THV. RISK FACTORS CORRELATING WITH SEVERAL PATIENT CO-MORBIDITIES HAVE BEEN IDENTIFIED. ALTHOUGH IN MANY CASES THE ROOT CAUSE OF THE EVENT IS UNABLE TO BE DETERMINED, STROKES DURING THV ARE UNDOUBTEDLY MULTIFACTORIAL, THE DOMINANT ETIOLOGY LIKELY BEING INTRA PROCEDURE EMBOLIC EVENTS. A TRANSCRANIAL DOPPLER STUDY DURING THV DEMONSTRATED THAT MOST PROCEDURAL EMBOLIC EVENTS OCCURRED DURING BALLOON VALVULOPLASTY, MANIPULATION OF CATHETERS ACROSS THE AORTIC VALVE, AND VALVE IMPLANTATION. AN ANALYSIS IN PATIENTS UNDERGOING VALVE SURGERY REVEALED FOUR BASELINE CHARACTERISTICS AND TWO PROCEDURAL EVENTS THAT WERE ASSOCIATED WITH EARLY POST-PROCEDURE STROKE: FEMALE SEX, EF < 30%, DIABETES, AGE OLDER THAN 70 YEARS, BYPASS PROCEDURE TIME> 120 MIN, AND CALCIFICATION OF THE ASCENDING AORTA. PREDICTORS OF LATE STROKE HAVE INCLUDED FEMALE SEX, AGE OLDER THAN 75 YEARS, ATRIAL FIBRILLATION, AND A HISTORY OF OR CURRENT SMOKING. THERE WERE NO SIGNIFICANT DIFFERENCES IN THE FREQUENCY OF LATE STROKES BETWEEN THV AND AVR PATIENTS. AFTER THV, THERE APPEARS TO BE A MORE CONSIDERABLE PROPORTION OF EARLY STROKES OCCURRING < 24 H POST-PROCEDURE, BUT THV PATIENTS WITH MULTIPLE CO-MORBIDITIES ARE PROBABLY AT HIGHER RISK OF BOTH EARLY AND LATE STROKES. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED, BUT INVESTIGATION RESULTS SUGGEST THAT FACTORS/MECHANISMS MENTIONED ABOVE CAUSED OR CONTRIBUTED TO THIS EVENT. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.
PER THE INSTRUCTIONS FOR USE (IFU), PARAVALVULAR LEAK (PVL) IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE. PARAVALVULAR LEAK REFERS TO BLOOD FLOWING THROUGH A CHANNEL BETWEEN THE STRUCTURE OF THE IMPLANTED VALVE AND THE LANDING ZONE, AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE TO THE TARGET SITE. SOME PVL IS NOT UNCOMMON POST-DEPLOYMENT. MANY CASES ARE MILD TO MODERATE, AND EITHER RESOLVE OVER TIME OR DO NOT CAUSE SYMPTOMS. OTHERS MAY BE MORE CLINICALLY SIGNIFICANT AND REQUIRE INTERVENTION. THE PATIENT SCREENING MANUAL AND THE PROCEDURE DIDACTIC IDENTIFY SEVERAL PROCEDURAL AND ANATOMICAL FACTORS WHICH COULD CONTRIBUTE TO PVL, INCLUDING DEVICE MALPOSITION, INACCURATE MEASUREMENT OF THE LANDING ZONE, UNEVEN DISTRIBUTION OF CALCIUM ON THE LANDING ZONE, BULKY OR SEVERE CALCIFICATION, AN ELLIPTICAL ANNULUS SHAPE, AND VALVE UNDER-SIZING. THE MECHANISM BEHIND WORSENING OR LATE PVL IS NOT WELL UNDERSTOOD BUT MAY BE RELATED TO CARDIAC REMODELING. HEMOLYSIS IS THE DESTRUCTION OF RED BLOOD CELLS. THERE ARE MULTIPLE EXTRINSIC AND INTRINSIC FACTORS INCLUDING USE OF EXTRACORPOREAL CIRCULATION, TRANSFUSION, INFECTION, TUMORS, AUTOIMMUNE DISORDERS, MEDICATION SIDE EFFECTS, A METABOLIC ABNORMALITY, AND RED BLOOD CELL MEMBRANE INSTABILITY. NORMAL RED BLOOD CELLS (ERYTHROCYTES) HAVE A LIFESPAN OF ABOUT 120 DAYS. AFTER THE LIFESPAN IS OVER THE RED BLOOD CELLS BREAK DOWN AND ARE REMOVED FROM THE CIRCULATION BY THE SPLEEN. IN SOME MEDICAL CONDITIONS, OR BECAUSE OF TAKING CERTAIN MEDICATIONS, THIS BREAKDOWN OF RED BLOOD CELLS IS INCREASED. MEDICATIONS THAT HAVE BEEN ASSOCIATED WITH HEMOLYSIS INCLUDE ACETAMINOPHEN, PENICILLIN, AND OTHER PAIN MEDICATIONS. RED CELLS MAY BE DESTROYED DUE TO DEFECTS IN THE CELLS THEMSELVES. ANOTHER CAUSE OF HEMOLYTIC ANEMIA IS BREAK DOWN DUE TO MECHANICAL DAMAGE, SUCH AS FROM ARTIFICIAL HEART VALVES OR HEART-LUNG BYPASS; OR THEY AS A RESULT OF TURBULENT BLOOD FLOW PATTERN AND ERYTHROCYTE DESTRUCTION CAUSED BY PVL OR CENTRAL REGURGITATION. EDWARDS EXTENSIVELY TRAINS PHYSICIANS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN TRANSCATHETER HEART VALVES (ALL MODELS). THE DEVICE TRAINING MANUALS INSTRUCTS THE OPERATOR ON PROPER IMAGING SCREENING REQUIREMENTS, INCLUDING THE USE OF GOOD QUALITY ECHOCARDIOGRAPHY AND/OR COMPUTED TOMOGRAPHY (CT) TO APPROPRIATELY MEASURE THE LANDING ZONE, ASSESS THE CONTENT AND DISTRIBUTION OF CALCIUM, AND OTHER PATIENT ANATOMICAL FACTORS. MULTIPLE IMAGING MODALITIES SHOULD BE CONSIDERED DURING VALVE SIZE SELECTION. CONTRAINDICATIONS, IMPORTANT CONSIDERATIONS WHEN ASSESSING THE VALVE, AND CHOOSING THE PROPER TRANSCATHETER HEART VALVE ARE ALSO DISCUSSED. THE DEVICE TRAINING MANUALS ALSO INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING PATIENTS SCREENING AND PROCEDURAL CONSIDERATIONS. DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS, AND PROCTORED PROCEDURES ARE ALSO INCLUDED. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. HOWEVER, INVESTIGATION RESULTS SUGGEST THAT PATIENT FACTORS (MILD ANNULAR CALCIFICATION, MODERATE STJ CALCIFICATION) AND/OR THE MECHANISMS MENTIONED ABOVE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PVL WITH HEMOLYTIC ANEMIA REQUIRING TRANSFUSION AND POST DILATION. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.
ON POST OPERATIVE DAY 6 AFTER THE TAVR, A CEREBRAL INFARCTION (CI) WAS OBSERVED.
AS REPORTED THROUGH THE JAPANESE TAVI REGISTRY, IMMEDIATELY AFTER A TRANSFEMORAL (TF) TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 26 MM SAPIEN 3 ULTRA RESILIA (S3UR) VALVE, MILD PARAVALVULAR LEAK (PVL) WAS OBSERVED. HEMOGLOBIN WAS 8.5 G/DL BEFORE THE TAVR, AND IT DECREASED TO 7.0 G/DL AFTER THE TAVR. ALTHOUGH BLOOD TRANSFUSION WAS PERFORMED MULTIPLE TIMES, LOW HEMOGLOBIN DID NOT IMPROVE. ON POST OPERATIVE DAY (POD) 33, PVL WAS MODERATE. POST DILATION WAS PERFORMED POD 37. AFTER THE POST DILATION, THE HEMOLYTIC ANEMIA WAS NOTED TO IMPROVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 972823 | EDWARDS LIFESCIENCES SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | 9755RSL26J |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male | Required Intervention |